SARACA jobs - CER Medical Writer

*  Effective communicators. People who can interpret information clearly

and accurately to concisely communicate results and recommendations to stakeholders, senior management, and their teams.

 *  Meticulous documenters. Detail-oriented people who enjoy maintaining

meticulous documentation of reports, metrics, proposals, and presentations.

 *  Self-directed imitators. People who take ownership of their work and

need no prompting to drive productivity, change, and outcomes.

 *  Collaborative partners. People who build and leverage cross-functional

relationships to bring together ideas, data and insights to drive continuous improvement in functions.

 *  Dedicated achievers. People who thrive in a fast-paced environment and

will stop at nothing to ensure a project is complete and meets regulations and expectations.

What you will do

As the Principal Medical Writer, you will represent the Clinical Science function on clinical project team. You will maintain responsibility for managing Clinical Science deliverables. You will work with confidential company data and you will interface with cross-functional internal and external stakeholders.

 *  Author clinical trial protocols, interim and final clinical study

reports, integrated safety/performance data summaries from raw data.

 *  Author Regulatory documents to support global regulatory requirements

e.g.: MDD/EU-MDR submissions (CER's, CEP, SSEP, PMCF Plans) to notified bodies to comply with requirements

 *  Author abstracts, manuscripts, publication figures, listings, posters

and slides

 *  Perform formal literature searches, and succinctly summarize

scientific content for assigned projects.

 *  Provide clinical science subject matter expertise and consultation to

Clinical Research Associates, Biostatistics, Data Management, Regulatory Affairs, Clinical Safety and other internal and external stakeholders.

 *  Collaborate with other staff to resolve complex or unclear situations.

 *  Propose and participate in departmental continuous improvement

initiatives.

 *  Assist in training staff.

Criteria

 *  A minimum of a Bachelor's Degree required; emphasis in health/science-related field preferred.

 *  10- 15 years of combined experience in clinical research, medical

writing, clinical science required.

*      Strong scientific and medical writing skills required, including

excellent word processing, visio and power point skills

*      Experience in writing clinical study reports, integrated summaries

of safety and performance, abstracts, manuscripts, clinical risk/benefit analyses, literature summaries required.

*      Experience in IDE / Class III products/ clinical trials preferred.

*      Previous knowledge of the Vascular space preferred.

*      Must be able to think analytically, have the ability to process

scientific and medical data, with the ability to multi-task and problem solve.

*      Must be able to work and make independent decisions, understand

complex scientific and clinical data information, and be able to take the initiative to lead projects and assignments.

*      Knowledgeable in AMWA code of ethics and appropriate guidelines

required.

*      Adept at word and power point processing, document management and

change control.

*      Excellent working knowledge of regulatory guidelines (FDA/CFR;

EN540/ Med DEV/GCP) and quality standards (ISO 14155/14971) and medical/scientific/disease state terminology preferred.